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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: acalabrutinib
Trade Name: CALQUENCE
Date Designated: 09/21/2015
Orphan Designation: Treatment of mantle cell lymphoma.
Orphan Designation Status: Designated/Approved
Acerta Pharma, LLC (a member of the AstraZeneca Group)
121 Oyster Point Boulevard
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: acalabrutinib
Trade Name: CALQUENCE
Marketing Approval Date: 10/31/2017
Approved Labeled Indication: treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Exclusivity End Date: 10/31/2024 
Exclusivity Protected Indication* :  treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
2 Generic Name: acalabrutinib
Trade Name: Calquence
Marketing Approval Date: 08/04/2022
Approved Labeled Indication: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Exclusivity End Date: TBD  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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